Analytical Development Manager
Job description
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
The Analytical Development Manager will function as a key member of the Process Development Services Team. You will collaborate with our clients to introduce new products.
This position will direct a team of analytical chemists to support analytical transfer, development, validation and troubleshooting activities to support our customers in developing medicines for patients.
Responsibilities:
- Provide technical support to the analytical development team
- Support troubleshooting and problem-solving activities and coach the team members to increase their capability
- Provide mentorship to the project teams to ensure that they achieve their results
- Lead analytical discussions with customers and communicate with SMEs in the Process Development, Project Management, QA, QC and IPC groups
- Ensure that safety standards and housekeeping standards are met and encourage a safety mindset
- Support compliance activities to ensure the team is ‘inspection ready’ at all times
- Lead analytical technology transfer activities for the site and transfer analytical methods to the QC and IPC labs.
- Instill a continuous improvement mentality in the team and look to improve and simplify ways of working
- Evaluate new analytical technologies
- Work closely with the chemistry development team to provide support to projects as required
- Support and guide the analytical chemists in their professional development ensuring that they have the required technical training and opportunities for personal growth.
- Author or contribute to regulatory submissions, patents and other internal documentation relevant to the role.
- Develop/Expand scientific, technical, and drug discovery knowledge by reading the peer reviewed scientific literature, attending scientific conferences and via relevant training
- Work with due care and attention, perform all quality, regulatory and safety duties in a compliant manner whilst acting always in accordance with the Dignity at Work Policy and Code of Conduct
Minimum Requirements/Qualifications:
- Degree, Masters or PhD in analytical chemistry.
- Extensive proven experience in an analytical chemistry environment. Experienced in analytical method development, troubleshooting, validation and transfer.
- Ideally some experience in a CDMO environment.
- Experience in managing a team.
- Proficient knowledge of analytical chemistry, particularly in method development, troubleshooting and analytical transfer.
- Experienced in HPLC, UPLC, GC, LC-MS, GC-MS, ICP
- Experienced in analytical technology transfer and in change control
- Proven ability to think critically and innovatively combined with willingness to challenge
- Demonstrated ability in troubleshooting and solving complex issues.
- A strong understanding of the regulatory and compliance requirements for analytical methods and specifications. Knowledge of ICH, FDA/EMA guidelines and USP, PH. Eur.
- Excellent technical writing skills and verbal communication are required to interact with all levels of our organization and clients.
- Ability to work with cross functional teams and engage with employees and customers at all levels.
- Adopt and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business.
What’s in it for you?
- Competitive base salary
- Annual bonus
- 25 days holiday + Good Friday + Christmas Eve
- Contributory Pension
- Private medical insurance
- Free onsite parking
About us
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.